The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab
Status unconfirmed · Phase 4
Conditions studied: Osteoporosis
In brief
This is a three-year study to evaluate the effect of sequential therapy of Forteo (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm.
Key facts
- Study ID
- NCT02130973
- Run by
- Health Research, Inc.
- People needed
- 60
- Starts
- 2013-08-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2017-08-31
Who can join
Age: 45 and older. Sex: female. Healthy volunteers: accepted.
You may not qualify if…
- The use of drugs known to affect skeletal or calcium homeostasis.
- Multiple vertebral fractures or severe lumbar degenerative changes with fewer than 2 evaluable lumbar vertebrae
- Current use of anti-resorptive medicines
- Use of Hormone/Estrogen Therapy, raloxifene or calcitonin within the past 3 months
- Use of oral bisphosphonate for more than 4 months within the past 2 years or more than 5 years total cumulative bisphosphonate use in the past 10 years
- Use of intravenous ibandronate within the past 18 months
- Use of intravenous zoledronic acid within the past 4 years
- A history of a symptomatic renal stone within the past 3 years or history of multiple symptomatic renal stones
- Skeletal Disorders other than osteoporosis including: Hypercalcemia, hyperparathyroidism, Paget's Disease or osteomalacia
- Untreated or uncontrolled thyroid disease
- Elevated Bone Specific Alkaline Phosphatase level
- History of external or internal radiation therapy
- Renal insufficiency with estimated GFR below 30 ml/min
- Liver function tests (ALT/AST) more than 1.5 times the upper limit of normal
- Clinically significant hyperuricemia or active gout
- Any contraindications to receipt of Teriparatide or Denosumab (including hypocalcemia)
- History of an atypical fracture of the femoral shaft
Where it is running
- Helen Hayes Hospital — West Haverstraw, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.